Periperal Blood Lymphocytes During Prostate RT

Prostate Cancer Clinical Trial

Official title:

A Pilot Study of Gamma H2AX DNA Repair Foci Kinetics in Peripheral Blood Lymphocytes During Prostate Cancer Radiotherapy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01899391
• Other study ID #: UHN REB 09-0136-CE
• Status: Withdrawn
• Phase: N/A
• First received: June 11, 2013
• Last updated: July 10, 2013
• Start date: August 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

Right now it is not possible to predict which patients are going to react more to RT. Many things could affect patient's response to radiation. One of the factors is whether the person can repair damage to the genetic material (DNA/RNA) caused by the RT. There is some evidence that a certain protein called Gamma H2AX is involved in DNA damage and repair and this can be used to predict the sensitivity of individual patients. The investigators will be studying this protein: Gamma H2AX) in the blood samples of prostate cancer patients exposed to both computed tomography (CT) scan and RT treatment. This will help us to understand why different individuals show differences in side effects following RT.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intermediate-risk prostate cancer patients (T1/T2N0M0 with either GS < 7 and PSA between 10-20 ng/ml or GS 7 and PSA less than 20 ng/ml).

• Planned for radical RT to the prostate with IMRT planning (79Gy/39fractions or 60 Gy/20 fractions).

• No contraindications to diagnostic CT scanning.

• Prostate volumes will be less than 80 cc to control the planning dose volume histogram (DVH) as much as possible in terms of rectal and bladder volumes.

• No known DNA repair disorders (e.g. family history of AT, BRCA1/2 or Li Fraumeni syndrome) or contraindications to radical pelvic RT.

Exclusion Criteria:

• Inability to provide informed consent.

• Patient having contraindications to diagnostic CT scan.

• Patients who have unobtainable data regarding previous therapy and their clinical outcome.

• Patients should not have any diagnostic X-rays or CAT scans 2 weeks prior to their enrollment into the study.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gamma H2AX in peripheral blood lymphocytes.		1 year	No
Secondary	Gamma H2AX following RT planning (CT scan).		1 year	No
Secondary	Gamma H2AX during RT		1 year	No